{ "FullStudy":{ "Rank":217734, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517529", "OrgStudyIdInfo":{ "OrgStudyId":"UC 11101915" }, "Organization":{ "OrgFullName":"University of Cincinnati", "OrgClass":"OTHER" }, "BriefTitle":"Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations", "OfficialTitle":"Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy" }, "StatusModule":{ "StatusVerifiedDate":"October 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 25, 2015", "ResultsFirstSubmitQCDate":"August 27, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"September 30, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 20, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 20, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Mohamed Tarek Shata", "ResponsiblePartyInvestigatorTitle":"Principal investigator", "ResponsiblePartyInvestigatorAffiliation":"University of Cincinnati" }, "LeadSponsor":{ "LeadSponsorName":"University of Cincinnati", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Merck Sharp & Dohme Corp.", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.", "DetailedDescription":"Objective 1: Evaluate the role of the immune responses in determining the emergence of HCV NS3 resistance mutation during protease inhibitor therapy\n\nHypothesis 1 (HT 1): Low HLA binding to peptides containing protease inhibitor resistance mutations is associated with the emergence of protease inhibitor mutants during therapy and failure of the treatment.\n\nHypothesis 2 (HT 2): A hole in T cell repertoire may allow emergence of protease inhibitor mutants during protease inhibitor therapy which leads to loss of the immune responses to these mutants and failure of treatment." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hepatitis C" ] }, "KeywordList":{ "Keyword":[ "Hepatitis C", "HCV" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Case-Only" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "BioSpec":{ "BioSpecRetention":"Samples With DNA", "BioSpecDescription":"Blood lymphocytes from enrolled subjects will be retained until all investigations will be performed and publications are generated. After that remaining samples will be discarded properly according to the Biosafety instructions." }, "EnrollmentInfo":{ "EnrollmentCount":"10", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"10 Hepatitis C infected subjects", "ArmGroupDescription":"10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy." } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants Who Completed Standard Treatment", "PrimaryOutcomeDescription":"Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.", "PrimaryOutcomeTimeFrame":"9 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of Participants Who Cleared the Virus", "SecondaryOutcomeDescription":"Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses", "SecondaryOutcomeTimeFrame":"9 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria: All chronically HCV-infected patients who fail peg-IFN and RBV therapy and are eligible for combined treatment with PI therapy will be enrolled. Briefly, this includes:\n\nMale or female\nAge 18 to 65\nChronic HCV infection evidenced by liver biopsy or persistent HCV viremia for >6 months\nTreatment experienced and classified as non-responder or relapser to prior interferon-based therapy.\n\nExclusion criteria:\n\nTreatment naïve chronically HCV-infected patients.\nPatients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.\nPregnancy\nHIV", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Investigators plan to enroll 20 human subjects with chronic hepatitis C virus infection from the outpatient clinic at the University of Cincinnati College of Medicine.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Mohamed Tarek. M Shata, MD, PhD", "OverallOfficialAffiliation":"University of Cincinnati", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of Cincinnati", "LocationCity":"Cincinnati", "LocationState":"Ohio", "LocationZip":"45267", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"26885675", "ReferenceType":"derived", "ReferenceCitation":"Abdel-Hameed EA, Rouster SD, Ji H, Ulm A, Hetta HF, Anwar N, Sherman KE, Shata MT. Evaluating the Role of Cellular Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy. Viral Immunol. 2016 May;29(4):252-8. doi: 10.1089/vim.2015.0093. Epub 2016 Feb 17." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"We plan to enroll 10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin (RBV) therapy (NR) and are therefore eligible for combined treatment with PI therapy according to the recent FDA approvals for Boceprevir. Patients will be recruited from the outpatient clinics at the University of Cincinnati College of Medicine", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"10 Hepatitis C Infected Subjects", "FlowGroupDescription":"10 chronically HCV-infected patients who failed the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin (RBV) therapy (NR)", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"10 Hepatitis C Infected Subjects", "BaselineGroupDescription":"10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"10" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Responders", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"55.3", "BaselineMeasurementSpread":"14.03" } ] } } ] } },{ "BaselineClassTitle":"Non responders", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"60.00", "BaselineMeasurementSpread":"5.29" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants Who Completed Standard Treatment", "OutcomeMeasureDescription":"Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.", "OutcomeMeasurePopulationDescription":"Measure HCV viral load and HCV-specific immune responses at baseline", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"9 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"10 Hepatitis C Infected Subjects", "OutcomeGroupDescription":"10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"complete standard treatment", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10" } ] } } ] } },{ "OutcomeClassTitle":"not complete", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants Who Cleared the Virus", "OutcomeMeasureDescription":"Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"9 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"10 Hepatitis C Infected Subjects", "OutcomeGroupDescription":"10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"responder", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"Non-responder", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"10 Hepatitis C Infected Subjects", "EventGroupDescription":"10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"10", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"10" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"Unrelated to the study", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"10" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Dr. Mohamed Tarek M Shata", "PointOfContactOrganization":"University of Cincinnati", "PointOfContactEMail":"mohamed.shata@uc.edu", "PointOfContactPhone":"(513) 558-6110" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006526", "ConditionMeshTerm":"Hepatitis C" },{ "ConditionMeshId":"D000006505", "ConditionMeshTerm":"Hepatitis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000008107", "ConditionAncestorTerm":"Liver Diseases" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000006525", "ConditionAncestorTerm":"Hepatitis, Viral, Human" },{ "ConditionAncestorId":"D000014777", "ConditionAncestorTerm":"Virus Diseases" },{ "ConditionAncestorId":"D000012327", "ConditionAncestorTerm":"RNA Virus Infections" },{ "ConditionAncestorId":"D000018178", "ConditionAncestorTerm":"Flaviviridae Infections" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8174", "ConditionBrowseLeafName":"Hepatitis", "ConditionBrowseLeafAsFound":"Hepatitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8175", "ConditionBrowseLeafName":"Hepatitis A", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8194", "ConditionBrowseLeafName":"Hepatitis C", "ConditionBrowseLeafAsFound":"Hepatitis C", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8193", "ConditionBrowseLeafName":"Hepatitis, Viral, Human", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16105", "ConditionBrowseLeafName":"Virus Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13732", "ConditionBrowseLeafName":"RNA Virus Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18907", "ConditionBrowseLeafName":"Flaviviridae Infections", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC02", "ConditionBrowseBranchName":"Viral Diseases" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" } ] } } } } } }